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FDA 510(k)

NEBULAIRE (IRC 1040) NEBULIZER PUMP

K-Number: K851436 · 1985-07-08

ApplicantInvacare Corp.
Decision Date1985-07-08
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

NEBULAIRE (IRC 1040) NEBULIZER PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Invacare Corp.. It received FDA 510(k) clearance on 1985-07-08 under 510(k) number K851436. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEBULAIRE (IRC 1040) NEBULIZER PUMP?

NEBULAIRE (IRC 1040) NEBULIZER PUMP is a medical device that received FDA 510(k) clearance on 1985-07-08. The listed applicant is Invacare Corp.. The 510(k) number is K851436.

When did NEBULAIRE (IRC 1040) NEBULIZER PUMP receive FDA 510(k) clearance?

NEBULAIRE (IRC 1040) NEBULIZER PUMP received FDA 510(k) clearance on 1985-07-08, under 510(k) number K851436.

Who is the listed applicant for NEBULAIRE (IRC 1040) NEBULIZER PUMP?

The FDA 510(k) record lists Invacare Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEBULAIRE (IRC 1040) NEBULIZER PUMP?

The FDA product code for NEBULAIRE (IRC 1040) NEBULIZER PUMP is CAF.

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Other records listing Invacare Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K071928THE INVACARE FLYER, MODEL IPC 100K070321TWILIGHT FULL FACE MASKK062402EASYSTAND EVOLVK061874INVACARE'S TWILIGHT II NASAL MASKSK033819INVACARE 3G TARSYSK031176INVACARE POLARIS EX HEATED HUMIDIFIER, MODEL ISP4000

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Related Devices (Code: CAF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254171Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210)Shenzhen Mericonn Technology Co., Ltd.K260270FindAir ONE for pMDI (FAO-MDI-V12-GRE-001)FindAir Sp. z o.o.K251572eRapid with eTrack SystemPari Respiratory Equipment, Inc.K251659Mesh Nebulizer (H6)Qingdao Future Medical Technology Co., Ltd.K244035Portable mesh nebulizer (JM821)Shenzhen Jermei Medical Device Technology Co., Ltd.K243468Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor Nebulizer (NB-1103)Joytech Healthcare Co. , Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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